Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT05439850
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2022-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for rotator cuff tears: debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in postoperative ultrasound imaging studies.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2022-06-18', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rotator cuff repair integrity', 'timeFrame': 'Preoperative to 1 year postoperative', 'description': 'absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.'}], 'secondaryOutcomes': [{'measure': 'PROMs scores for upper extremity function', 'timeFrame': 'Preoperative to 2 years postoperative', 'description': 'Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.'}, {'measure': 'PROMs scores for depression', 'timeFrame': 'Preoperative to 2 years postoperative', 'description': 'Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).'}, {'measure': 'PROMs scores for upper extremity pain interference', 'timeFrame': 'Preoperative to 2 years postoperative', 'description': 'Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse).'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': 'Preoperative to 2 years postoperative', 'description': 'Standard range of motion values collected by the surgeon during preoperative and followup visits'}, {'measure': 'Shoulder Strength', 'timeFrame': 'Preoperative to 2 years postoperative', 'description': "Standard shoulder strength values collected by the surgeon during preoperative and followup visits. Medical Research Council Manual Muscle Testing scale will be used to measure the patient's strength on a 0 to 5 scale with 0 being the minimum and 5 being the maximum. Higher scores are better/normal."}, {'measure': 'Complications', 'timeFrame': 'Intraoperative to 2 years postoperative', 'description': 'Both intra- and postoperative complications will be collected.'}, {'measure': 'Reoperation', 'timeFrame': '2 years postoperative', 'description': 'Whether or not patients required another operation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Tear', 'Bioinductive', 'Arthroscopic Rotator Cuff Repair', 'Rotator Cuff Tear Arthropathy'], 'conditions': ['Rotator Cuff Tears', 'Rotator Cuff Tear Arthropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.', 'detailedDescription': 'A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indicated and scheduled for arthroscopic rotator cuff repair.\n* Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.\n* Chronic, degenerative rotator cuff tears.\n* Ability to read and understand English.\n* Age ≥18 years\n* Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy\n\nExclusion Criteria:\n\n* Patient scheduled for open or mini-open rotator cuff repair\n* Prior surgery of affected shoulder (except diagnostic arthroscopy)\n* Partial-thickness rotator cuff tears\n* Small (\\<1 cm) rotator cuff tears\n* Rotator cuff tears involving the subscapularis tendon\n* Acute and traumatic rotator cuff tears\n* Active infection\n* Cancer\n* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus'}, 'identificationModule': {'nctId': 'NCT05439850', 'briefTitle': 'Bioinductive Patch for Full-Thickness Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '15702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.', 'interventionNames': ['Procedure: arthroscopic rotator cuff repair', 'Diagnostic Test: Ultrasound Imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.', 'interventionNames': ['Procedure: arthroscopic rotator cuff repair', 'Biological: Bioinductive implant', 'Diagnostic Test: Ultrasound Imaging']}], 'interventions': [{'name': 'arthroscopic rotator cuff repair', 'type': 'PROCEDURE', 'description': 'This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.', 'armGroupLabels': ['Control Group', 'Study Group']}, {'name': 'Bioinductive implant', 'type': 'BIOLOGICAL', 'otherNames': ['Bioinductive patch'], 'description': 'A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.', 'armGroupLabels': ['Study Group']}, {'name': 'Ultrasound Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'An ultrasound will be performed on each patient one year postoperatively.', 'armGroupLabels': ['Control Group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johnny Kasto, MD', 'role': 'CONTACT', 'email': 'jkasto1@hfhs.org', 'phone': '3132448078'}, {'name': 'Stephanie J Muh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'Johnny Kasto, MD', 'role': 'CONTACT', 'email': 'jkasto1@hfhs.org', 'phone': '313-244-8078'}, {'name': 'Stephanie J Muh, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Stephanie J Muh, MC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Service Chief, Principal Investigator', 'investigatorFullName': 'Stephanie Muh, MD', 'investigatorAffiliation': 'Henry Ford Health System'}}}}